(Steps f to i continue until a final document is agreed by ANZ VICH MG.)

Step j: ANZ response is submitted to the working group (when ANZ has an expert) or to VICH SC (when there is a local coordinator).

ANZ VICH experts/coordinators

There are two participating roles in VICH working groups: experts and coordinators. While the experts interact directly with the appropriate VICH working groups, the coordinators act locally by coordinating an ANZ position on VICH guidelines when an ANZ expert has not been nominated.

Roles of experts

Act as the central liaison point for all written and oral communication in relation to the working group

Consult with peers in Australia and New Zealand (industry and government), from a listing developed in conjunction with ANZ VICH MG

Prepare de novo an ANZ submission to the working group, which incorporates the views of industry and government.

Consolidate responses within ANZ on guidelines and provide recommendations for submission to the working group

Provide ANZ VICH MG with appropriate comment on the working group deliberations and decisions

Attend meetings of the working group as the ANZ representative

As appropriate, attend meetings of ANZ VICH MG to report on working group activities

Obtain ANZ VICH MG approval for documents to be submitted to the working group.

Roles of coordinators

Liaise with the ANZ VICH secretariat for all communications with VICH in relation to the working group

Act as the central liaison point for all written and oral communication in relation to the working group documents received through ANZ VICH MG

Consult with peers in Australia and New Zealand (industry and government), from a listing developed in conjunction with ANZ VICH MG

Prepare the ANZ submission to VICH, which incorporates the views of industry and government

As appropriate, attend meetings of ANZ VICH MG to report on working group activities

Obtain ANZ VICH MG approval for documents to be submitted to the working group.

Benefits of VICH for Australia and New Zealand

Regulatory certainty

Uniform requirements

Predictable regulatory environment

Time limits for regulatory process

Economics of scale

Scientific principles rather than socio-economic considerations the mainstay of the approval process.

Reduced animal testing

Elimination of duplicate testing

Introduction of uniform in vitro testing methods.

Ready-made model

VICH model offers framework for harmonisation

Adapts human pharmaceutical work to veterinary sector

Complements work of Codex and JECFA.

Removal of trade barriers

Harmonisation leads to increased free trade

Applies to both veterinary and food products

Observer countries are major food exporters.

Consumer safety

Requirements based on scientific principles reinforce credibility of regulatory process and food standards.

Transparent and uniform process improves consumer perceptions of and confidence in food safety.

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